Physicians, clinical trial administrators, and product formulators lack effective security mechanisms for ensuring that patients and clinical trial participants taking self-administered medications and other products adhere to medical prescriptions and clinical trial protocols. They also have very limited product delivery choices for ensuring the delivery of precise amounts of medicine and other products that are self-administered by patients and clinical trial participants. Conventional delivery systems for products under prescription and clinical study, such as medication, nicotine, herbal products, pain killers, sleep aids, dietary stimulants, dietary suppressants, etc., also lack effective security mechanisms to prevent unauthorized product use and confirm that only the authorized user has taken an authorized product in accordance with an authorized protocol. This hampers the ability of physicians, clinical trial administrators, and product formulators to assess patient absorption rates, product efficacy, side effects, and optimize product formulations and dispensing techniques. They also lack effective, secure and authenticated electronic techniques for gathering per-dose data and user feedback related to the benefits and side effects from in-home, self-administrated products. This need applies generally to many types of products under prescription, clinical trial, or experimental testing.
As medical marijuana (“MMJ”) continues to become legalized across the United States and worldwide, physicians prescribing MMJ treatment options for select patients will benefit from understanding the MMJ product options and medicines available by licensed MMJ cultivators and formulators. Conventional technology does not provide an automatically updated database of available MMJ medicines and patient efficacy information that physicians can reference to assist in making informed decisions when selecting MMJ formulations and treatment regimes. Traditionally, doctors refer to the Physician's Desk Reference (“PDR”) for guidance on selecting and prescribing medications. But the current PDR does not even contain a category for MMJ. A need therefore exists for new techniques to provide physician guidance to assist in identifying patient conditions suitable for MMJ treatment and prescribing MMJ products well suited to the specific needs of patients with various conditions.
At the same time, a wide range of MMJ products are continually being developed containing precise strains of cannabis and carefully crafted combinations of cannabinoid extracts formulated and tested to be effective for specific ailments. For example, specific MMJ formulations are in various stages of development, clinical testing, approval and deployment for epilepsy, insomnia, intractable pain, migraine headaches, PTSD, Parkinson's, essential tremor, and other ailments. Typically, each ailment is most responsive to a specific MMJ formulation, and the search for specific MMJ formulations to treat a range of ailments is an ongoing industry focus. While many of these conditions are very serious and in desperate need of effective treatments, the MMJ products under consideration are generally considered relatively benign as compared to many other types of medications under development, such as chemotherapies. Less stringent clinical trial and experimental product testing procedures, such as in-home, patient-administered options, may therefore be considered appropriate for MMJ formulations. But cannabis is a well-known recreational drug and there are no in-home, patient-administered MMJ administration systems currently available that provide adequate safeguards to ensure that only authorized patients take the cannabis medications according to authorized protocols.
Another major challenge within the MMJ industry is that there are no consistent and very precise dispensing and delivery methods for MMJ products that can be recommended with confidence by physicians to their patients. Simply instructing patients to smoke a quantity of cannabis flower produces widely varying results among patients. Smoking cannabis is the most unsafe method for consuming the drug due to the carbonization of plant material during the combustion phase. The majority of states that allow MMJ use therefore do not permit the sale or medicinal use of plant material (leaves/flowers/buds) for smoking. Most states instead require the MMJ processors to use extraction processes that remove the beneficial oils from the plant material to form a liquid concentrate of cannabinoids and terpenes. This oil can then be used to produce alternate forms of MMJ consumption. One common method of prescribing the oil is in the form of a vape pen, similar to an electronic cigarette. The oil is combined with a carrier agent and then package in a cylindrical cartridge that contains an internal heating coil. The cartridge is then attached to a battery powered device which heats the coil to a high temperature to vaporize the mixture, allowing the patient to inhale the oil. Again, the heat required to vaporize the oil destroys many of the beneficial cannabinoids in the oil. Other factors that negatively affect the ability to control dispensing through inhalation include inconsistent inhalation depth and duration by the patient (long or short inhale), how long the inhaled product is held in the lungs by the patient (2 seconds or 20 seconds). The primary advantage to smoking or vaping MMJ is that “time to onset” is relatively quick and the effects of the MMJ is generally felt by the patient in only a few minutes. Ingesting edible MMJ products typically has a much longer time to onset, up to an hour, as well as a longer duration of the effect.
Other types of MMJ products include packaging the extracted oils in gel tablets, tinctures in glass bottles with eye droppers or in the form of edible products. The quantity of MMJ product ingested by the patient is virtually impossible to verify, as is the amount of the prescribed product that makes it through the patient's digestive system and into the bloodstream. Stomach acids destroy and the liver filters out many of the beneficial cannabinoids in the medicine. For example, when a patient ingests a 10 mg gel tab, after traveling through the digestive tract, only 15% to 30% of the medicine is typically absorbed into the bloodstream. MMJ ingestion again poses challenges for physicians in controlling accuracy and consistency in the delivery of the medicine. Bioavailability is also heavily impacted when smoking or vaping MMJ because the amount of cannabinoids that are destroyed or damaged by combustion or extreme heating is significant. A need therefore exists for new MMJ product delivery techniques that do not rely on burning or vaporizing the MMJ product at the time of consumption.